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A Study to Evaluate Efficacy and Safety of Ustekinumab Re-induction Therapy in Participants With Moderately to Severely Active Crohn's Disease (POWER)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03782376
Recruitment Status : Recruiting
First Posted : December 20, 2018
Last Update Posted : August 5, 2020
Sponsor:
Information provided by (Responsible Party):
Janssen-Cilag Ltd.

Brief Summary:
The primary purpose of this study is to evaluate the efficacy and safety of a single intravenous (IV) re-induction dose of approximately 6 milligram per kilogram (mg/kg) ustekinumab in participants with secondary loss of response (LoR) to subcutaneous (SC) every 8 Weeks (q8w) 90 mg ustekinumab maintenance therapy.

Condition or disease Intervention/treatment Phase
Crohn Disease Drug: Ustekinumab approximately 6 mg/kg (IV) Drug: Placebo (SC) Drug: Placebo (IV) Drug: Ustekinumab 90 mg (SC) Group 1 Drug: Ustekinumab 90 mg (SC) Group 2 Phase 3

Detailed Description:
This study compares the efficacy and safety of a single weight-tiered based IV re-induction dose of approximately 6 mg/kg ustekinumab versus continuing with regular SC q8w 90 mg ustekinumab administration. It consists of screening (5 weeks); treatment period (Week 0 to 24); and safety follow up visit (20 weeks after last dose). The primary hypothesis is that a single IV re-induction dose of ustekinumab is superior to continuing with regular SC q8w maintenance treatment as measured by clinical response after 16 weeks of treatment. Study assessments will include Crohn's disease activity index (CDAI), video ileocolonoscopy, patient-reported outcomes (PROs), laboratory evaluations, biomarkers, review of concomitant medications and adverse events (AEs), and evaluation of serum concentrations of study agent as well as development of antibodies to study agent. All participants will be randomly assigned to receive either ustekinumab IV re-induction or regular SC q8w 90 mg ustekinumab injection at baseline in a double dummy design. No participants will be treated with placebo only.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 3b, Randomized, Double-blind, Multicenter Study to Evaluate the Safety and Efficacy of Intravenous Re-induction Therapy With Ustekinumab in Patients With Moderately to Severely Active Crohn's Disease
Actual Study Start Date : December 20, 2018
Estimated Primary Completion Date : June 28, 2022
Estimated Study Completion Date : November 30, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Crohn's Disease
Drug Information available for: Ustekinumab

Arm Intervention/treatment
Experimental: Group 1: Ustekinumab (IV re-induction)
Participants who experience a secondary loss of response (LoR) to 90 mg ustekinumab maintenance treatment, administered subcutaneously every 8 weeks (q8w) will receive a weight-tiered based ustekinumab IV re-induction dose of approximately 6 mg/kg and matching placebo subcutaneously at Week 0. At Weeks 8 and 16, all participants will receive SC maintenance injections of 90 mg ustekinumab. Participants will resume their standard-of-care therapy at Week 24 at the discretion of the treating physician.
Drug: Ustekinumab approximately 6 mg/kg (IV)
Participants will receive ustekinumab approximately 6mg/kg intravenously at Week 0.
Other Name: STELARA

Drug: Placebo (SC)
Participants will receive SC injection of placebo at Week 0.

Drug: Ustekinumab 90 mg (SC) Group 1
Participants will receive SC injection of ustekinumab 90 mg at Weeks 8 and 16.
Other Name: STELARA

Active Comparator: Group 2: Ustekinumab (Continuous q8w SC maintenance)
Participants who experience a secondary LoR to 90 mg ustekinumab maintenance treatment, administered subcutaneously q8w will receive ustekinumab 90 mg subcutaneously and matching placebo intravenously at Week 0. At Weeks 8 and 16, all participants will receive SC maintenance injections of 90 mg ustekinumab. Participants will resume their standard-of-care therapy at Week 24 at the discretion of the treating physician.
Drug: Placebo (IV)
Participants will receive IV infusion of placebo at Week 0.

Drug: Ustekinumab 90 mg (SC) Group 2
Participants will receive SC injection of ustekinumab 90 mg at Weeks 0, 8 and 16.
Other Name: STELARA




Primary Outcome Measures :
  1. Percentage of Participants with Clinical Response at Week 16 [ Time Frame: Week 16 ]
    Percentage of participants with clinical response at Week 16 will be assessed. Clinical response is defined as a greater than or equal to (>=) 100 point reduction from the baseline Crohn's Disease Activity Index (CDAI) score or a CDAI score less than (<) 150 points (in general, CDAI score ranges from 0 to approximately 600; higher score indicates higher disease activities). CDAI will be assessed by collecting information on 8 different Crohn's disease-related variables (extra-intestinal manifestations, abdominal mass, weight, hematocrit, total number of liquid stools, abdominal pain/cramping, use of antidiarrheal drug(s) and/or opiates, and general well-being). A decrease in CDAI over time indicates improvement in disease activity.


Secondary Outcome Measures :
  1. Percentage of Participants with Clinical Remission at Week 16 [ Time Frame: Week 16 ]
    Percentage of participants with clinical remission at Week 16 will be assessed. Clinical remission is defined as a CDAI score of < 150 points.

  2. Percentage of Participants with Clinical Response at Week 8 [ Time Frame: Week 8 ]
    Percentage of participants with clinical response at Week 8 will be assessed. Clinical response is defined as a >=100 point reduction from the baseline CDAI score or a CDAI score <150 points.

  3. Percentage of Participants with Clinical Remission at Week 8 [ Time Frame: Week 8 ]
    Percentage of participants with clinical remission at Week 8 will be assessed. Clinical remission is defined as a CDAI score of < 150 points.

  4. Percentage of Participants with Normalization of CRP at Week 16 [ Time Frame: Week 16 ]
    Normalization of C-reactive protein is defined as C-reactive protein (CRP) <=3 milligram/liter (mg/L). Percentage of participants with normalization of CRP will be measured at Week 16 among the participants having abnormal baseline CRP (> 3 mg/L).

  5. Percentage of Participants with Normalization of Fecal Calprotectin Concentration at Week 16 [ Time Frame: Week 16 ]
    Percentage of Participants with Normalization of Fecal Calprotectin Concentration (<250 mg/kg) at Week 16 will be assessed. Fecal Calprotectin will be monitored as a sensitive and specific marker measured by assay.

  6. Percentage of Participants with Clinical Remission at Week 24 [ Time Frame: Week 24 ]
    Percentage of participants with clinical remission at Week 24 will be assessed. Clinical remission is defined as a CDAI score of < 150 points.

  7. Percentage of Participants with Clinical Response at Week 24 [ Time Frame: Week 24 ]
    Percentage of participants with clinical response at Week 24 will be assessed. Clinical response is defined as a >=100 point reduction from the baseline CDAI score or a CDAI score <150 points.

  8. Percentage of Participants with Normalization of CRP at Week 24 [ Time Frame: Week 24 ]
    Normalization of C-reactive protein is defined as C-reactive protein (CRP) <=3 milligram/liter (mg/L). Percentage of participants with normalization of CRP will be measured at Week 24 among the participants having abnormal baseline CRP (> 3 mg/L).

  9. Percentage of Participants with Normalization of Fecal Calprotectin Concentration at Week 24 [ Time Frame: Week 24 ]
    Percentage of Participants with Normalization of Fecal Calprotectin Concentration (<250 mg/kg) at week 24 will be assessed. Fecal Calprotectin will be monitored as a sensitive and specific marker measured by assay.

  10. Percentage of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs) [ Time Frame: Up to Week 36 ]
    The percentage of participants with at least one adverse event and subcategories of adverse events will be assessed. An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. SAE is any AE that results in: death, persistent or significant disability/incapacity, requires inpatient hospitalization or prolongation of existing hospitalization, is life-threatening experience, is a congenital anomaly/birth defect and may jeopardize participant and/or may require medical or surgical intervention to prevent one of the outcomes listed above.

  11. Percentage of Participants with Infections and Serious Infections [ Time Frame: Up to Week 36 ]
    Percentage of participants with infections and serious infections will be reported.

  12. Number of Participants with Clinical Laboratory Abnormalities [ Time Frame: Up to Week 24 ]
    Number of participants with laboratory abnormalities will be reported. Blood samples for serum chemistry and hematology will be collected at predefined time points for clinical laboratory testing.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  • A history of Crohn's disease or fistulizing Crohn's disease of at least 3 months' duration, with colitis, ileitis, or ileocolitis, confirmed at any time in the past by radiography, histology, and/or endoscopy
  • Currently receiving subcutaneous 90 mg every 8 weeks (q8w) ustekinumab maintenance therapy and initially responded to ustekinumab induction therapy, administered according to the local label, followed by secondary loss of response (LoR) to ustekinumab. Secondary LoR to ustekinumab is defined as active disease at study baseline, proven by a Crohn's Disease Activity Index (CDAI) score of greater than or equal to (>=) 220 and <=450 with at least one of the following: Elevated C-reactive protein (CRP) (>3.0 milligram per liter [mg/L]); and/or elevated Fecal calprotectin (FeCa) >250 milligram per kilogram [mg/kg]); and/or endoscopy (performed less than or equal to (<=) 3 months before baseline) with evidence of active Crohn's disease, (defined as one or more ulcerations in the ileum and/or colon)
  • Participants receiving either oral 5-aminosalicylic acid (5-ASA) compounds, oral corticosteroids (for example {e.g.}, prednisone, budesonide) at a prednisone-equivalent dose of <=40 mg/day or <=9 mg/day of budesonide, antibiotics used as the primary treatment of Crohn's disease, or conventional immunomodulators (i.e., azathioprine [AZA], 6-mercaptopurine [6-MP], or methotrexate [MTX]) are permitted providing the doses indicated are stable before baseline or have been discontinued before baseline within the protocol defined durations

Exclusion Criteria:

  • Complications of Crohn's disease, such as symptomatic strictures or stenoses, short gut syndrome, or any other manifestation that might be anticipated to require surgery, could preclude the use of the CDAI to assess response to therapy, or would possibly confound the ability to assess the effect of treatment with ustekinumab
  • Currently has or is suspected to have an abscess. Recent cutaneous and perianal abscesses are not exclusionary if drained and adequately treated at least 3 weeks before baseline (or 8 weeks before baseline for intra-abdominal abscesses) provided there is no anticipated need for any further surgery. Participants with active fistulas may be included if there is no anticipation of a need for surgery and there are currently no abscesses identified
  • Any kind of bowel resection within 6 months or any other intra-abdominal surgery within 3 months before baseline
  • A draining (i.e., functioning) stoma or ostomy
  • Received any off-label use of ustekinumab, including additional intravenous (IV) re-induction or shortened frequency of subcutaneous dose administration after the initial weight-tiered based IV induction dose of ustekinumab

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03782376


Contacts
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Contact: Study Contact 844-434-4210 JNJ.CT@sylogent.com

Locations
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Sponsors and Collaborators
Janssen-Cilag Ltd.
Investigators
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Study Director: Janssen-Cilag Ltd. Clinical Trial Janssen-Cilag Ltd.
Additional Information:
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Responsible Party: Janssen-Cilag Ltd.
ClinicalTrials.gov Identifier: NCT03782376    
Other Study ID Numbers: CR108533
2018-002629-51 ( EudraCT Number )
CNTO1275CRD3008 ( Other Identifier: Janssen-Cilag Ltd. )
First Posted: December 20, 2018    Key Record Dates
Last Update Posted: August 5, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description:

The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinical-trials\transparency.

As noted on this site, requests for access to the study data can be submitted through Yale open and Access (YODA) Project site at yoda.yale.edu

URL: https://www.janssen.com/clinical-trials/transparency

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Crohn Disease
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Ustekinumab
Dermatologic Agents